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Urinary Bladder, Overactive clinical trials

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NCT ID: NCT03194425 Active, not recruiting - Overactive Bladder Clinical Trials

Standardization of Lead Placement for Sacral Neuromodulation. Part 1

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Retrospective case-control study. A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract dysfunction characteristics as the ones with good responses. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.

NCT ID: NCT03156088 Active, not recruiting - Overactive Bladder Clinical Trials

Clinical and Urodynamic Predictors for Sacral Neuromodulation Outcomes in Overactive Bladder

Start date: January 1, 2012
Phase: N/A
Study type: Observational [Patient Registry]

Overactive bladder syndrome (OAB) is a prevalent disorder that affects about 10% of the adult population and > 40% of elderly. It is defined by the presence of urgency, with or without urge incontinence, in the absence of infection or other pathology. In 1997 through 1999, sacral nerve stimulation SNS (InterStim, Medtronic Inc., Minneapolis, Minnesota) was approved by the U.S. Food and Drug Administration (FDA) for treating urge urinary incontinence, urinary urgency, and frequency. Despite the large numbers of SNS performed, the only objective clinical evaluation of OAB is urodynamic detrusor instability (UDI) with some evidence suggesting a correlation with outcomes after sacral neuromodulation. Interestingly, the mechanism of action of SNS is not fully understood. Theories include direct activation of efferent fibers to the striated urethral sphincter causing reflex relaxation of the detrusor or potential activation of afferent fibers selectively which can lead to inhibition at spinal and supraspinal levels. Somatic sacral afferent inflow activation at sacral level affects the storage and emptying reflexes in the bladder and central nervous system, explaining the beneficial effects of neuromodulation on both storage and emptying functions of the bladder. Malaguti and his colleagues detected somatosensory evoked potentials during sacral neuromodulation, revealing that sacral neuromodulation works by both sacral afferent activity and somatosensory cortex activation. As sacral neuromodulation is clinically proven for both storage and emptying bladder dysfunctions, it is difficult to isolate its action to either sacral afferent or efferent circuits in the micturition reflex pathway. In our study, we are going to study sacral neuromodulation outcome predictors from the clinical and urodynamic perspectives in order to help identifying the right candidates for sacral neuromodulation procedure.

NCT ID: NCT02619721 Active, not recruiting - Clinical trials for Refractory Overactive Bladder

Clinical Trial of Sacral Neuromodulation for Treatment of Refractory Overactive Bladder (OAB)

Start date: October 2015
Phase: Phase 0
Study type: Interventional

Evaluate the long-term clinical effectiveness and safety of the PINS Sacral Neuromodulation to patients with refractory Overactive Bladder.

NCT ID: NCT02456441 Active, not recruiting - Clinical trials for Urinary Bladder, Overactive

Effects of TENS in Autonomous System in Women With Overactive Bladder

Start date: March 2014
Phase: N/A
Study type: Interventional

The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical syndrome characterized by urgency with or without urge incontinence , usually accompanied by frequency and nocturia , since in the absence of proven infection or other pathology related . The negative impact on quality of life of patients with OAB is already known. The etiology and pathophysiology of OAB are not completely understood. However, studies indicate an alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way . However, no studies in the literature evaluating the effect of electroconvulsive therapy on the mechanisms involved in sympathetic and parasympathetic modulation in these women . The objective of this study is to investigate the effects of TENS on the sympathetic and parasympathetic system in women with OAB . This is a randomized, double -blind , which will be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2 groups : TENS group and placebo group. Interventions take place in one day assessment of the sympathetic and parasympathetic nervous system are performed . After collecting the data will be analyzed in accordance with the statistical analysis.

NCT ID: NCT02060214 Active, not recruiting - Clinical trials for Urinary Frequency/Urgency

Development of Novel Cystometrics for Overactive Bladder

Start date: January 2014
Phase:
Study type: Observational

Urinary urgency is the key symptom of overactive bladder (OAB). A critical barrier in understanding OAB is the lack of a method to separate urgency that derives directly from bladder filling or what we term "tension sensor output" and urgency that derives from abnormal brain interpretation. The central hypothesis is that measureable biomechanical parameters can directly affect the output (urgency) of the detrusor tension sensor. The development of novel cystometric tests for the improved diagnosis and treatment of OAB and for the potential identification of novel mechanistic targets in the pathophysiology of OAB.

NCT ID: NCT01848366 Active, not recruiting - Overactive Bladder Clinical Trials

Biowave Overactive Bladder Trial

OAB
Start date: May 2013
Phase: N/A
Study type: Interventional

Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.

NCT ID: NCT01750645 Active, not recruiting - Clinical trials for Urinary Bladder, Overactive

Management of the Idiopathic Overactive Bladder With Botulinum Toxin: Systematic Review

Start date: July 2012
Phase: N/A
Study type: Observational

Overactive bladder is defined as a syndrome composed of urgency, increased urinary frequency, and sometimes urinary incontinence; its etiology may be characterized as neurogenic or non-neurogenic (i.e., idiopathic). This illness has a great impact in quality of life and one of the available treatments is the injection of Botulinum Toxin. This study aims to review the efficacy and safety of type-A Botulinum Toxin in the management of Idiopathic Overactive Bladder. A systematic search was performed in MEDLINE, EMBASE, CENTRAL and LILACS, and the controlled randomized clinical trials were chosen to review with the CONSORT criteria by independent reviewers. Outcomes analyzed were the efficacy of the intervention for relieving the symptoms (urgency, frequency and urgency incontinence), adverse events to treatment, change in quality of life and urodynamic measures.

NCT ID: NCT00628615 Active, not recruiting - Clinical trials for Lower Urinary Tract Symptoms

Non-Micturation Bladder Activity in Relation to Self-Consciousness During Filling Phase and Sensation Measurement During the Filling Phase

Start date: April 2008
Phase: N/A
Study type: Observational

Rationale: The sensation of the need for urination (urge) is a complex and only partially understood mechanism. It is our hypothesis that this mechanism is disrupted in patients suffering from overactive bladder syndrome. The Overactive Bladder syndrome (OAB) has been defined as a spectrum of symptoms in which incontinence may or may not overlap with urgency, frequency and nocturia. This syndrome is estimated to affect approximately 17% of the adult population in Europe and the United States. The symptoms of overactive bladder have many potential causes and contributing factors. One of these factors is an outlet obstruction of the bladder due to benign prostatic hyperplasia (BPH). Nowadays antimuscarinic drugs are used for treatment of the overactive bladder. Antimuscarinic agents have been proven to work slightly to moderately better than placebo's and are associated with side effects such as a dry mouth, blurred vision and constipation. Many patients with lower urinary tract symptoms (LUTS) develop OAB. In this group of patients with LUTS and OAB, there is not always a clear obstruction found. So, at least in some patients, with LUTS, there must be another reason for OAB than obstruction. The autonomous bladder activity has been introduced by, among others the Maastricht Urology research group. In animal models, the bladder is shown to have rhythmic low amplitude contractions (micro motions). It is hypothesized that this activity has a sensory function in the micturation regulation system which is mainly located in the bladder wall. These so called micromotions have never been demonstrated in the human bladder. The sensing function of the bladder and the micturation reflex remain mainly unclear. We hypothesise that there is a disregulation of the autonomous bladder activity (micro motions) in patients with OAB. We want to explore and study the relationship between OAB, obstruction and the micro motions in order to gain a better understanding of the bladder (patho)physiology. reason for This on its turn, can help us in the quest for better treatment strategies for patients suffering from OAB. Objective: The study is divided in two distinct groups a male and female group: The male group consist of patients with lower urinary tract symptoms (LUTS). The female group consist of patients with the overactive bladder syndrome OAB. The primary objective of this pilot experiment is to describe via an observational study the relation between non-micturation bladder activity and sensation during the filling phase of the bladders in women. We want to explore if there is a relation between non-micturation bladder activity and the sensation of urgency during the filling phase. Furthermore in men, we want to study the relationship between non-micturation bladder activity and the amount of obstruction. We would also like to visualize the micro motions of the bladder in both men and women during filling phase and study the influence of (visual and cognitive) stimuli on bladder activity. We want to explore if there is a relation between non-micturation bladder activity and the sensation of urgency during the filling phase in male patients with Lower urinary tract symptoms. In order to gain a better understanding in bladder (patho)physiology. Study design: A pilot observational study to describe the non-micturation bladder activity and sensation measurement during filling phase. Study population: The study population consists of two groups. First a group of patients (female) who will undergo an ambulatory urodynamic investigation to investigate their bladder complaints. All patients will be older than 18 years. The second group consists of male patients who will undergo a conventional urodynamic investigation in the normal work up for their lower urinary tract symptoms. All patients will be older than 18 years.